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PharmaCompass offers a list of Rofecoxib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rofecoxib manufacturer or Rofecoxib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rofecoxib manufacturer or Rofecoxib supplier.
PharmaCompass also assists you with knowing the Rofecoxib API Price utilized in the formulation of products. Rofecoxib API Price is not always fixed or binding as the Rofecoxib Price is obtained through a variety of data sources. The Rofecoxib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rofecoxib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rofecoxib, including repackagers and relabelers. The FDA regulates Rofecoxib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rofecoxib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Rofecoxib supplier is an individual or a company that provides Rofecoxib active pharmaceutical ingredient (API) or Rofecoxib finished formulations upon request. The Rofecoxib suppliers may include Rofecoxib API manufacturers, exporters, distributors and traders.
click here to find a list of Rofecoxib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rofecoxib DMF (Drug Master File) is a document detailing the whole manufacturing process of Rofecoxib active pharmaceutical ingredient (API) in detail. Different forms of Rofecoxib DMFs exist exist since differing nations have different regulations, such as Rofecoxib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rofecoxib DMF submitted to regulatory agencies in the US is known as a USDMF. Rofecoxib USDMF includes data on Rofecoxib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rofecoxib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rofecoxib suppliers with USDMF on PharmaCompass.
Rofecoxib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Rofecoxib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Rofecoxib GMP manufacturer or Rofecoxib GMP API supplier for your needs.
A Rofecoxib CoA (Certificate of Analysis) is a formal document that attests to Rofecoxib's compliance with Rofecoxib specifications and serves as a tool for batch-level quality control.
Rofecoxib CoA mostly includes findings from lab analyses of a specific batch. For each Rofecoxib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Rofecoxib may be tested according to a variety of international standards, such as European Pharmacopoeia (Rofecoxib EP), Rofecoxib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rofecoxib USP).